Combining toripalimab with chemotherapy for advanced gastric cancer

Toripalimab Combined With FLOT Regimen in Locally Advanced Gastric cancer-a Prospective, Open, Multi-center, Phase Ⅱ Clinical Study

This study is testing if combining a new drug called toripalimab with chemotherapy can help people with advanced stomach cancer do better before surgery.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Henan Cancer Hospital (other gov)
• Drugs / interventions: radiation, prednisone, toripalimab, chemotherapy
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT04891016 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of neoadjuvant chemoimmunotherapy using toripalimab combined with FLOT chemotherapy in patients with locally advanced gastric and gastroesophageal junction cancer. Participants are divided into two groups, receiving treatment on different days of their chemotherapy cycles, followed by surgical intervention. The study aims to evaluate the pathological complete response and median disease-free survival among the participants. Preliminary results indicate no significant differences in outcomes between the two treatment regimens.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 70 with resectable locally advanced gastric adenocarcinoma and specific health criteria.

Not a fit: Patients with distant metastasis or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with locally advanced gastric cancer.

How similar studies have performed: While similar approaches have been explored, this specific combination of treatments is relatively novel and under investigation.

Eligibility criteria

Inclusion Criteria:

* 70 ≥ Age ≥ 18 years regardless of gender
* Gastric adenocarcinoma confirmed by pathology
* no distant metastasis and resectable or potentially resectable evaluated by general surgery experts
* ECOG PS 0-1
* clinical stage T3/4 or N+ by AJCC 8.0
* PD-L1 CPS ≥1 (IHC 22C3 pharm Dx assay (Dako))
* expected lifespan over 3 months
* Adequate organ function: 1) without growth factor and blood component support in the first 2 weeks of enrollment; 2) Cardiac function: no heart disease or coronary heart disease, grade 1-2; 3) liver function: TBIL ≤ 2ULN, AST ≤ 2.5 ULN, alt ≤ 2.5 ULNX 4 Renal function: cr ≤ 1.25ULN, liver function: TBIL ≤ 2ULN, TBIL ≤ 2.5ULN, alt ≤ 2.5ULN, 4)renal function: cr ≤ 1.25ULN.
* blood pressure normal or controlled within the normal range by antihypertensive drugs
* Diabetic patients were treated with hypoglycemic drugs to control fasting blood glucose ≤ 8mmol/L
* Patients with positive hepatitis B surface antigen need to be tested for quantitative detection of hepatitis B DNA virus. HBV DNA should be less than the upper limit of the normal test value for patients with HBV infection.
* no other serious diseases conflicting with this study
* No history of other malignant tumors
* Women of childbearing age must be tested negative for blood pregnancy test within 7 days before enrollment, and subjects of childbearing age must use appropriate contraceptive measures during the trial and within 6 months after the trial
* agreement to participate in this study and signed the informed consent form

Exclusion Criteria:

* Pregnant or lactating women
* Suffered from severe infectious diseases within 4 weeks before entering the group
* Bronchial asthma requires intermittent use of bronchodilators or medical intervention
* Due to the use of immunosuppressants before coexisting diseases and the dosage of immunosuppressants ≥ 10mg/, the oral dose of prednisone lasted for more than 2 weeks
* Clinically obvious cardio-cerebrovascular diseases, including, but not limited to, severe acute myocardial infarction, instability or severe angina pectoris, coronary artery bypass surgery, congestive heart failure, ventricular arrhythmias requiring medical intervention, left ventricular ejection fraction \< 50%, stroke within 6 months
* Allergic to any experimental drug and its excipients, or have a history of severe allergy, or are contraindications to experimental drugs
* Severe mental disorders
* Abnormal coagulation function (PT \> 16s, APTT \> 53s, TT \> 21s Fib \< 1.5g/L), bleeding tendency or undergoing thrombolysis or anticoagulation therapy
* Past or present pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, severe impairment of lung function, etc.
* Unable to swallow research drugs, chronic diarrhea (including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis) and intestinal obstruction affect drug use and absorption
* Have a history of immunodeficiency, including positive for HIV, or suffer from other acquired, congenital immunodeficiency diseases, or have a history of organ transplant
* Other researchers evaluate those who do not meet the criteria for admission

Where this trial is running

Zhengzhou, Henan

• Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital — Zhengzhou, Henan, China (RECRUITING)

Study contacts

• Principal investigator: Quanli Gao, M.D — Department of Immunotherapy, Henan Provincial Cancer Hospital
• Study coordinator: Quanli Gao, M.D

Conditions: Chemotherapy, Immune Checkpoint Inhibitor, Locally Advanced Gastric Carcinoma